Precision Medicine Group - Safety Lead

• Essential functions of the job include but are not limited to: • Interfacing with sponsors, vendors, and other internal team members in the area of safety/PV to assist in the design and implementation of safety collection tools, processes, and reporting systems. • Participate in the assessment and set-up of a safety database to capture SAE data. • QC of documents and safety reports when needed. • Preparation and/or review of project specific safety reporting plans and medical coding plans • Preparation and/or review of safety training materials • Review of Safety related budget tasks and activities • Develop and manage standard operating procedures and work instructions. • Serve as subject matter expert for department. • Provide ongoing training and mentorship for Safety Specialists • Participate in audits and audit preparation, kick-off meetings, and investigator meetings. • Participate in the CAPA management process. • Participate in bid defenses for existing and potential clients. • Assist departmental management with resource management. • Assist departmental management with oversight. • Serve as project manager for safety standalone projects. • Lead departmental initiatives and cross-functional development activities. • Support the generation of SAE/AESI queries and tracking including oversight in the query resolution escalation efforts. • Provide input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities. • Assist clients and/or other departmental staff with safety-related reviews and other services.